FDA approves Eylea (Regeneron) for wet AMD

The FDA has approved Eylea (aflibercept ophthalmic solution), from Regeneron, to treat patients with wet (neovascular) Age-related Macular Degeneration (AMD), a leading cause of vision loss and blindness in Americans ages 60 and older. There are two forms of AMD, a wet form and a dry form. The wet form of AMD includes the growth of abnormal blood vessels which can leak fluid into the central part of the retina (macula). When this occurs the macula thickens and vision loss occurs. The safety and effectiveness of Eylea was evaluated in two clinical trials involving 2,412 adult patients. People in the study received either Eylea or Lucentis (ranibizumab injection). The primary endpoint in each study was a patient�s clearness of vision (visual acuity) after one year of treatment. The studies showed that Eylea was as effective as Lucentis in maintaining or improving visual acuity. The most commonly reported side effects in patients receiving Eylea included eye pain, blood at the injection site (conjunctival hemorrhage), the appearance of floating spots in a person�s vision (vitreous floaters), clouding of the eye lens (cataract), and an increase in eye pressure. Other FDA-approved treatment options for wet AMD include: Visudyne (verteporfin for injection) approved in 2000, Macugen (pegaptanib sodium injection) approved in 2004, and Lucentis (ranibizumab injection) approved in 2006.